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J&J MedTech Completes Pilot Enrollment for OMNY-AF Study on Atrial Fibrillation Treatment
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US major Johnson & Johnson (J&J, NYSE: JNJ) MedTech has announced the completion of pilot phase enrollment for the OMNY-AF study, which is assessing the effect of its OMNY-AF platform in symptomatic paroxysmal atrial fibrillation (AFib) in the United States and Australia. The single-arm, multi-center study aims to enroll up…
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Innorna Co., Ltd Receives FDA Rare Pediatric Disease Designation for mRNA Drug IN015
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Shenzhen-based Innorna Co., Ltd has announced that it has received Rare Pediatric Disease Designation (RPDD) from the US Food and Drug Administration (FDA) for its proprietary mRNA drug, IN015, developed for the treatment of progressive familial intrahepatic cholestasis (PFIC). Understanding PFIC and the Impact of IN015Progressive familial intrahepatic cholestasis (PFIC)…
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Teva Pharmaceutical Reports Positive Phase III Results for TEV-‘749 in Schizophrenia Trial
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Israel-based Teva Pharmaceutical Industries Ltd (NYSE: TEVA) has released new positive data on social functioning and quality of life from the Phase III Subcutaneous Olanzapine Extended-Release Injection Study (SOLARIS) trial. The study assesses the efficacy of TEV-‘749 in adult patients diagnosed with schizophrenia. SOLARIS Study Design and TEV-‘749’s EfficacyThe SOLARIS…
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Neurodawn Pharmaceutical Secures Hundreds of Millions in Series C Financing
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Nanjing-based central nervous system (CNS) drug developer, Neurodawn Pharmaceutical Co., Ltd, has announced the successful completion of a Series C financing round, raising hundreds of millions of renminbi. The funding was led by Nanjing Jiangning High Tech Zone Science and Technology Entrepreneurship Investment Management Co., Ltd and Huaxing Kangping Pharmaceutical…
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Suzhou Basecare Medical’s BKA210 Receives Marketing Approval in Jiangsu Province
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China-based in vitro fertilization (IVF) specialist Suzhou Basecare Medical Co., Ltd (HKG: 2170) has announced that it has received marketing approval for its intelligent sperm quality analyzer, BKA210, in Jiangsu province. This marks the world’s first device capable of detecting unstained live sperm, offering a significant advancement in the field…
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Reprogenix Secures Over RMB100 Million in Series A Financing Led by China Venture Capital
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Hangzhou-based stem cell specialist Reprogenix has announced the successful completion of a Series A financing round, raising in excess of RMB100 million (USD14.04 million). The funding round was led by China Venture Capital, with participation from Betta Pharmaceuticals Co., Ltd (SHE: 300558) contributing RMB 20 million, Lenovo Capital and Incubator…
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Novo Nordisk’s Semaglutide Meets Primary Endpoints in ESSENCE Phase III Study for MASH
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Denmark-based pharmaceutical company Novo Nordisk (NYSE: NVO; CPH: Novo-B) has announced that part 1 of the Phase III ESSENCE study, a pivotal 240-week, double-blinded trial involving 1,200 adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis, has successfully reached its primary endpoints. The trial evaluated the efficacy…
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Jiuzhitang Co., Ltd Announces Clinical Clearance for Volagidemab in Type 1 Diabetes
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China-based traditional Chinese medicine (TCM) giant Jiuzhitang Co., Ltd (SHE: 000989) has announced that volagidemab (REMD-477), a Category 1 drug developed by Beijing CoSci-REMD Bio Med-Tech Co, Ltd (CoSci-REMD Bio), a subsidiary of U.S. biotech REMD Biotherapeutics Inc., has received clearance for clinical study in type 1 diabetes in China.…
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Shenzhen Chipscreen Biosciences Receives NMPA Approval for Chiauranib Clinical Study
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China-based biopharmaceutical company Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321) has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its category 1 innovative drug, chiauranib. The study will evaluate chiauranib in combination with a programmed-death (PD)-(ligand) 1 monoclonal antibody and chemotherapy as a…
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Innovent Biologics Halts Subscription Agreement with Lostrancos Ventures
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced the decision not to proceed with a subscription agreement between its wholly owned subsidiary, Fortvita, and Lostrancos Ventures Ltd. The agreement would have seen Lostrancos acquire a 20% stake in Fortvita for USD 20.5 million. Despite this setback, Innovent Biologics reaffirmed its…
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AstraZeneca’s China President Leon Wang Confirmed to Assist in Investigation Amid Fraud Allegations
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On October 29, 2024, just hours after celebrating a business school anniversary on social media, AstraZeneca’s (AZ, NASDAQ: AZN) Global Executive Vice President and China President, Leon Wang, was confirmed to be cooperating with an investigation. The announcement came less than 48 hours later via AstraZeneca China’s official website. On…
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Novartis’ Trispecific Antibody PIT565 Secures NMPA Approval for Clinical Trial
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has received acceptance for its clinical trial application for the investigational drug PIT565 from the China National Medical Products Administration (NMPA). PIT565 is a potential “first-in-class” trispecific antibody targeting CD3, CD19, and CD2, which Novartis is developing to treat B-cell malignancies. Preclinical research results…
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Shenzhen Chipscreen Biosciences’ Tivozanib Secures NMPA Approval for ES-SCLC Phase III Trial
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Shenzhen Chipscreen Biosciences Co., Ltd. (SHA: 688321) has announced that the National Medical Products Administration (NMPA) has approved its New Drug Application (NDA) for Tivozanib in combination with PD-(L)1 monoclonal antibodies and chemotherapy as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). Tivozanib, a novel multi-target inhibitor developed…
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Humanwell Healthcare Receives NMPA Approval for Compound Sodium Lactate Ringer’s Injection
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Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) has received approval from the National Medical Products Administration (NMPA) for the registration of its compound sodium lactate Ringer’s injection. The product, classified as a Class 3 chemical drug, has been granted marketing approval and is considered to have passed consistency evaluation. The…
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MSD Reports 4% YOY Revenue Increase in Q3 2024, Led by Pharmaceutical Sector
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US pharmaceutical giant Merck, Sharp & Dohme Inc., (MSD; NYSE: MRK) has released its financial report for the third quarter of 2024, highlighting a 4% year-on-year (YOY) increase in revenues to USD 1.67 billion. The Pharmaceutical sector experienced a 5% YOY growth, reaching USD 14.943 billion, while the Animal Health…
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Regeneron Pharmaceuticals Reports 11% YOY Revenue Growth in Q3 2024
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US-based Regeneron Pharmaceuticals (NASDAQ: REGN) has reported its financial details for the third quarter of 2024, with revenues reaching USD 3.72 billion, marking an 11% increase year-on-year (YOY). Product sales grew by 9% YOY to USD 1.946 billion, while collaboration revenues stood at USD 1.774 billion, up 12.5% YOY. In…
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AbbVie Partners with EvolveImmune to Develop Immunotherapies for Cancer
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US pharmaceutical company AbbVie (NYSE: ABBV) has entered into a collaboration and option-to-license agreement with EvolveImmune Therapeutics, Inc., an immunotherapy platform company backed by industry giants including Pfizer (NYSE: PFE) and BMS (NYSE: BMY). The partnership will focus on leveraging EvolveImmune’s T-cell engager platform to develop novel antibody-based therapies for…
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CARsgen Therapeutics’ Suspended CAR-T Therapies Get FDA Green Light to Resume
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The US Food and Drug Administration (FDA) has removed the suspension on clinical studies for three chimeric antigen receptor (CAR)-T therapies developed by CARsgen Therapeutics Holdings Ltd (HKG: 2171), according to the company’s statement to the Hong Kong Stock Exchange. The therapies include CT053 (zevorcabtagene autoleucel), a BCMA-targeted CAR-T therapy…
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AIM Vaccine Submits Market Filing for 13-Valent Pneumococcal Conjugate Vaccine in China
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced the submission of a market filing for its in-house developed 13-valent pneumococcal conjugate vaccine to the National Medical Products Administration (NMPA). Streptococcus pneumoniae disease is a high-priority target for vaccine prevention efforts. The 13-valent pneumococcal conjugate vaccine is designed for infants…
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Eisai and Biogen Complete BLA Submission for Alzheimer’s Drug Leqembi to FDA
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Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have jointly announced the completion of a rolling submission of a Biologics License Application (BLA) for their co-developed Alzheimer’s disease drug Leqembi (lecanemab) to the U.S. Food and Drug Administration (FDA). The submission seeks approval for Leqembi as a subcutaneous…
